—#103085

Product

UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot/Serial Numbers: All

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed that the Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results.

Root cause (FDA determination)

Component design/selection

Action the firm took

Beckman Coulter sent an URGENT: Product Corrective Action letter to all affected customers. The letter provided customers with an explanation of the problem identified and actions to be taken. The letter instructs customers to share this information with their laboratory staff and retain a copy as part of their laboratory Quality System documentation. In addition, the letter states that if the affected product was further distributed to provide a copy of the letter to them. Customers were also asked to complete and return the enclosed Response Form. For any questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2010-09-02
Posted by FDA: 2012-01-11
Terminated: 2014-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.